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The ACUITY Break-Away™ Lead Delivery System is intended to access the coronary venous system and may be used alone (8F) or in dual catheter delivery (8F with 6F). The system serves as a conduit for the delivery of contrast medium and devices, including implantable coronary venous leads, introduced into the coronary venous system.

The ACUITY Break-Away™ Delivery System consists of two guide catheters plus the following accessories: torque device, guidewire introducer and cutter. The system is designed to provide venous access and to aid with the selective placement of implantable venous leads in the left cardiac vasculature. The catheters, provided in a 8F size and 6F size models, are packaged separately. The 8F catheter package also contains the torque device and guidewire introducer accessories, which assist with implanting the lead, and the cutter, which is used to facilitate removal of the catheters after implant. The 6F catheter is packaged alone. The 8F catheter may be used by itself or in conjunction with the 6F catheter in a telescoping manner to improve the access and delivery capabilities of the system. The ACUITY Break-Away catheter models feature a hub that is manually split apart rather than cut, and also incorporate a hemostasis valve to eliminate the need for an external accessory valve. The catheter is designed with a flexible distal segment and a soft tip to atraumatically enter the main coronary sinus and branch veins. The 6F ACUITY Break-Away catheter must be used with an 8F ACUITY Break-Away guide catheter to gain access to the main coronary sinus.

The Boston Scientific ACUITY™ Universal Cutter is intended to be used with Guidant or Boston Scientific cuttable families of guiding catheters, and is intended to facilitate guiding catheter removal after the Guidant or Boston Scientific coronary venous lead is positioned.

The Cutter is an accessory manufactured for use with cuttable guiding catheters, to facilitate removal of the catheter following lead placement. The Cutter attaches to the lead and cuts one wall of the guiding catheter as it is removed from the patient, allowing the guiding catheter to be removed from the lead. The Cutter consists of three sections: a molded plastic handle, a stainless steel blade and a lead management section. The lead management section secures and stabilizes the lead prior to and during the cutting procedure. After the lead has been positioned in the patient, the cutter is connected to the lead body as close to the catheter hub as possible. Holding the cutter stationary and fixed to a surface, the implanter pulls the catheter against the cutter blade. The hub is cut first, followed by the catheter section.